This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer
The trial consist of Screening Period (30 days), Treatment Period (21\*n days), Safety Follow-up Period (90 days) and Survival follow-up. About 20 subjects are planned to be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The WTX212A infusion is given every 21 days
The PD -1/PD-L1 monoclonal antibody is given every 21 days
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGTo evaluate the efficacy of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of patients with IO- resistant advanced lung cancer.
Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1
Time frame: 1 year
the safety of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer patients
The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of WTX212A injection
Time frame: 1 year
To evaluate the pharmacokinetic ( PK ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer
Peak Plasma Concentration (Cmax)
Time frame: 1 year
To evaluate the immunogenicity of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO -resistant advanced lung cancercheckpoint inhibitor resistance in advanced lung cancer patients
Describe the percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment
Time frame: 1 year
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